Tougher device/diagnostics approval regulations in the EU appear increasingly likely in the wake of the continent's recent breast implant scandal.
The scandal over the now-defunct French implant maker Poly Implant Prothese hasn't been forgotten. European scientists are now pursuing an additional study focusing on the health and safety of patients who received those implants, after an initial finding late last year that women who received them were at a greater risk for health problems than those who didn't. But EU health and consumers chief John Dalli also sounded the first drumbeat of a larger regulatory response late last week, Reuters reports.
Dalli told a news conference he's asked health ministers from all 27 EU countries to maximize existing rules and review the dozens of regulatory agencies--many are private companies--that handle approvals for high-risk medical devices. The end goal is to make sure that the notified bodies--the groups that handle device approvals--are only evaluating and approving devices that fit with their specific, respective expertise, according to the Reuters article.
Meanwhile, industry group Eucomed issued a statement supporting the effort, and the European Commission's push to improve device safety approval procedures in the long term with changes such as surprise inspections. The EC has said the initial steps will boost surveillance of medical devices and diagnostics as it pursues a larger regulatory overhaul.
"I have asked my colleagues in the member states for their personal commitment to implementing these actions as a matter of priority," Dalli is quoted by Reuters as saying.
- here's the Reuters article